Johnson & Johnson MedTech · 2 days ago
Compliance Specialist IV
Johnson & Johnson MedTech is a leader in healthcare innovation, focused on preventing, treating, and curing complex diseases. The Compliance Specialist IV will develop and oversee Quality and Compliance programs for Med Tech US field inventory, ensuring regulatory compliance and driving improvements in partnership with various stakeholders.
Hospital & Health Care
Responsibilities
Develop, execute, and oversee Quality and Compliance (Q&C) programs for Med Tech US field inventory within the North America Region, including Field Inventory Locations (FIL), Field Sales Offices, Loaner Sites, and Distribution Centers (DC)
Support “last mile” delivery of surgical loaner sets support joint reconstruction and orthopedic customers across the US
Serve as a liaison with Quality, Distribution, Sales, Commercial, and Supply Chain partners on distribution quality related matters to drive timely resolution of quality related issues
Identify and support implementation of improvement opportunities consistent with business objectives and the Enterprise Quality Standards
Define, implement, and validate quality requirements and systems in alignment with departmental strategies
Participate in and lead audits, inspections, investigations, and remediation activities
Ensure the Quality program maintains regulatory compliance
Provide quality support for existing and new distribution processes
Develop, implement, and review standard operating procedures
Establish and maintain relationships with NA DELIVER, DePuy Synthes Sales Inc., and other Med Tech Franchise customers in order to solve problems and meet changing competitive and regulatory environments
Execute and improve systems/processes in Inspection readiness; Commercial Quality including field inventory consignment and Loaner programs; Process changes; Validation, Calibration, and Preventive Maintenance systems; Delivery service issue trending; and Nonconformance investigation and corrective action plan development, implementation, and effectiveness monitoring
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
6 years of experience in the job offered or in a Compliance Specialist IV-related occupation
Benefits
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.